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RegisterDissolution and bracketing [Regulatives / Guidelines]
Hi and thanks for your response.
Just to make sure I’m understanding correctly:
Do I need to do a BE study on all the strengths that are not showing similarity in dissolution
Or
Can I use bracketing approach and just add one study, either on the lowest strength or the strength differing most in dissolution?
Thanks for your help.
Susan
Just to make sure I’m understanding correctly:
- I have generic IR product for EU submission
- There are 5 strengths that are dose proportional
- All the General biowaiver criteria are fulfilled except the f2 similarity is not achieved between the highest strength (used in BE study) and the lower strengths
Do I need to do a BE study on all the strengths that are not showing similarity in dissolution
Or
Can I use bracketing approach and just add one study, either on the lowest strength or the strength differing most in dissolution?
Thanks for your help.
Susan
Complete thread:
- Dissolution and bracketing - EMA Susanh 2020-03-19 18:39 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dissolution and bracketing - EMA ping4santosh 2020-03-20 11:38
- Dissolution and bracketing wienui 2020-03-21 17:39
- Dissolution and bracketingSusanh 2020-04-03 11:56
- Dissolution and bracketing (EMA) wienui 2020-04-04 08:42
- Dissolution and bracketingSusanh 2020-04-03 11:56
Ing. Helmut Schütz